Plain English Summary
Background and study aims
In recent years, dental lasers have been used for the non-surgical treatment of periodontal (gum) diseases. However, it is unclear whether lasers are effective at improving treatment for chronic periodontitis (inflammation of the gums). This study aims to determine whether the use of a laser called Er:YAG is more effective than the traditional treatment of scaling and root planing (SRP) for periodontal diseases in a Chinese population.
Who can participate?
Chronic periodontitis patients aged between 35-70 in Beijing
What does the study involve?
The study design involves splitting the patient's mouth into two sides - a test side and a control side. Teeth were randomly allocated into the test side or the control side i.e. if teeth on the left hand side were allocated test group, the right hand side will be the control group. Participants in the test group will receive laser treatment and traditional SRP treatment, whereas participants in the control group will receive traditional SRP treatment only. To determine the effectiveness of the treatment, participants will have a clinical examination involving assessment of their probing depth, clinical attachment level, bleeding index and plaque index. For the test and control groups, treatment will occur at 0 months, 3 months and 6 months. Treatment will occur after a clinical examination.
What are the possible benefits and risks of participating?
A benefit of participating is that patients will receive traditional periodontal treatment, along with free laser treatment for those in the test group. There is the risk of a small amount of pain in the gum for 1-2 days after treatment.
Where is the study run from?
Department of Stomatology, Beijing Chao-Yang Hospital, Beijing
When is the study starting and how long is it expected to run for?
March 2015 to December 2017
Who is funding the study?
1. The Beijing Science and Technology Committee (China)
2. National Natural Science Foundation of China (China)
Who is the main contact?
Prof. Zhou
xuanzhou2004@hotmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Xuan Zhou
ORCID ID
http://orcid.org/0000-0003-2522-1283
Contact details
Department of Stomatology
Beijing Chao-Yang Hospital
Capital Medical University
Chao Yang District
Beijing
100020
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Z151100004015100
Study information
Scientific title
Efficacy of Er:YAG laser on chronic periodontitis as an adjunctive non-surgical treatment: a split-mouth randomized controlled study
Acronym
Er:YAG laser in Periodontal Treatment
Study hypothesis
Er:YAG laser combined with conventional scaling and root planing (SRP) may provide more effective adjunctive treatment than SRP alone
Ethics approval
Ethics Committee of the Beijing Chao-Yang Hospital, 14/11/2014, No: 2014-Sci-157
Study design
Interventional single-blinded single centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Moderate or severe chronic periodontitis
Intervention
Using a split-mouth design, two quadrants (one quadrant from each jaw) were randomly allocated to either the test or control group. The quadrants in the test group received Er:YAG laser (ERL) plus scaling and root planing (SRP) treatment, while the quadrants in the control group received SRP only.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Periodontal probing was used to measure the following at the baseline, after 3 months and after 6 months:
1. Probing depth (PD)
2. Clinical attachment level (CAL)
Secondary outcome measures
The following were measured at the baseline, after 3 months and after 6 months:
1. Bleeding index (BI) assessed through periodontal probing
2. Plaque index (PLI) assessed by an examiner using a scale of 0 to 3 with the following definitions:
- 0: No plaque
- 1: Cannot see plaque but plaque can be detected with probe
- 2: Moderate plaque can be seen
- 3: Lots of plaque can be seen
Overall trial start date
01/11/2014
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 35-70 years
2. Minimum of 16 teeth (4 per quadrant)
3. At least one site with probing depths (PD) ≥4 mm in each quadrant, with bleeding on probing
4. Good general health
5. Non-smoker
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
27
Total final enrolment
27
Participant exclusion criteria
Possible participants were excluded if they 1) had received periodontal treatment within the previous 6 months; 2) had received systemic antibiotic therapy within the previous 6 months; 3) had suffered systemic diseases that could influence the outcome of therapy, such as diabetes mellitus or blood disease; 4) were pregnant; or 5) were smokers.
1. Received periodontal treatment within the previous 6 months
2. Received systemic antibiotic therapy within the previous 6 months
3. Suffered systemic diseases that could influence therapy outcome (e.g. diabetes mellitus, blood disease)
4. Pregnant
Recruitment start date
01/03/2015
Recruitment end date
30/04/2017
Locations
Countries of recruitment
China
Trial participating centre
Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University
No.8 GongRenTiYuChangNanLu, Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University, Chao Yang District
Beijing
100020
China
Sponsor information
Organisation
Beijing Chao-Yang Hospital, Capital Medical University
Sponsor details
No.8 GongRenTiYuChangNanLu
Department of Stomatology
Beijing Chao-Yang Hospital
Capital Medical University
Chao Yang District
Beijing
100020
China
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
the Beijing Science and Technology Program Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
the National Natural Science Foundation of China
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intending to publish in the Journal of Clinical Periodontology in 2019.
IPD sharing statement
The trial individual data were collected and are maintained by the Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. The corresponding author takes full responsibilities for the acquisition, management, analysis, and interpretation of data for this trial. The trial individual data will not be made available to the public but may be available for researchers upon their reasonable request.
Intention to publish date
01/02/2019
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN18400416 _BasicResults_04Jan19docx.pdf
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31069833 (added 09/08/2019)
Publication citations
Additional files
- ISRCTN18400416 _BasicResults_04Jan19docx.pdf Uploaded 15/01/2019